Permanent Injunction to Limit Distribution of Adulterated External Defibrillators

[nitpicker]

https://www.justice.gov/opa/pr/district-court-enters-permanent-injunction-against-philips-north-america-and-two-executives

Department of Justice
Office of Public Affairs

FOR IMMEDIATE RELEASE

Tuesday, October 31, 2017

District Court Enters Permanent Injunction Against Philips North America and Two Executives to Limit Distribution of Adulterated External Defibrillators

A federal court enjoined Philips North America LLC (Philips) and two of the company’s executives from distributing certain medical devices, including some of the company’s external defibrillators, until the company takes remedial steps, the Department of Justice announced today. The U.S. District Court for the District of Massachusetts entered a consent decree of permanent injunction against Philips, headquartered in Andover, Massachusetts, and two of the company’s executives, Carla Kriwet and Ojas Buch. Ms. Kriwet is the business group leader for the Patient Care and Monitoring Solutions (PCMS) business group within Philips. Mr. Buch is Vice President, Head of Quality and Regulatory for the PCMS business group. With limited exceptions, the consent decree permanently enjoins the defendants from distributing certain medical devices until remedial steps are undertaken.
(snip)

The Department filed a complaint in the District of Massachusetts on Oct. 11, at the request of the U.S. Food and Drug Administration (FDA). As alleged in the complaint, FDA inspected Philips’ Bothell, Washington, facility in 2015. The inspection revealed that company had failed to establish and maintain adequate procedures for implementing corrective and preventive action as required by federal regulation. Specifically, the complaint alleged that while Philips initiated corrective and preventive action in response to complaints involving certain resistor failures during the use of the HeartStart HS1 and FRx defibrillators, Philips’ corrective actions did not fully address the problem with the devices in the field and Philips continued to receive complaints about the failure.

The complaint also alleged that another 2015 inspection by FDA at Philips’ Andover, Massachusetts, facility revealed the company’s failure to establish and maintain adequate procedures for implementing corrective and preventive action in connection with the company’s Q-CPR meter (a device that provides feedback on chest compressions during cardiopulmonary resuscitation), and for design verification in connection with a change to a battery used in the Heartstart MRx defibrillator.

The permanent injunction enjoins defendants, with limited exceptions, from manufacturing or distributing certain Emergency Care & Resuscitation devices until it can demonstrate that it has undertaken required remedial measures. The injunction also orders Philips to issue notifications with respect to its Q-CPR meters, and external defibrillators manufactured with a specific resistor. For the external defibrillators covered by the notice and still under warranty, Philips will provide a refurbished exchange unit at no cost; if the device is no longer under warranty, customers may be eligible for a trade-in rebate. Furthermore, the injunction requires Philips to take specific steps with respect to the company’s other PCMS business units at its Andover and Bothell facilities. Those steps include hiring an expert consultant to inspect these business units to ensure, among other things, that the methods and controls used to manufacture and distribute Philips’ PCMS devices comply with the federal Food, Drug, and Cosmetic Act and its implementing regulations.
(snip)

[hlthe2b]

2. How sad to see these malfunction...

One would think quality control would be paramount for Phillips. sigh...

[justhanginon]

3. Unfortunately, it seems today the paramount concern

for corporations is profit and their managements stock options price. All else is considered secondary. Whether it be in manufacturing or the financial industry the health or safety of the consumer comes in later, sometimes much later.